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To compare the efficacy of Kampo treatment and fenoprofen as antipyretics in patients with common cold syndrome associated with fever.

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Evidence Reports of Kampo Treatment

Task Force for Evidence Reports / Clinical Practice Guideline Committee for EBM, the Japan Society for Oriental Medicine

950006e

10. Respiratory Diseases (including Influenza and Rhinitis) Reference

Homma Y. Kampo treatment of patients with common cold syndrome associated with fever. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1995; 46: 285–91 (in Japanese with English abstract). CiNii

1. Objectives

To compare the efficacy of Kampo treatment and fenoprofen as antipyretics in patients with common cold syndrome associated with fever.

2. Design

Randomaized controlled trial using sealed envelopes for allocation (RCT-envelope).

3. Setting

Medical Administration Center, Hokkaido University, Japan.

4. Participants

Out of 246 patients with common cold, 80 patients with a temperature of 37°C or higher (Hokkaido University students) were included.

5. Intervention

Arm 1: administration of Kampo extracts (manufacturers, not specified): kakkonto (葛根湯; n=18), maoto (麻 黄 湯, n=9), keimakakuhanto (桂 麻 各 半 湯, n=3), chikujountanto (竹 筎 温 胆 湯, n=2), shoseiryuto (小青竜湯, n=1), keishikashakuyakuto (桂枝加芍薬湯, n=1), or kososan (香蘇散, n=1) 2.5 or 3.0 g t.i.d. according to sho (証, pattern) (total n=35).

Arm 2: adminstration of fenoprofen 400 mg t.i.d. (n=45).

6. Main outcome measures

Duration of fever, percentage of patients with fever during the course of treatment, rebound of fever, and duration of cold symptoms.

7. Main results

The duration of fever was significantly shorter in arm 1 (1.5±1.9 days) than in arm 2 (2.6±1.7 days; P<0.001). The percentage of patients with fever was significantly higher and the duration of cold symptoms was longer in arm 2 than in arm 1.

8. Conclusions

Kampo treatment is more effective than fenoprofen, an antipyretic used for fever associated with common cold.

9. From Kampo medicine perspective

Kampo prescriptions were administered according to sho in patients with fever associated with common cold.

10. Safety assessment in the article

None.

11. Abstractor’s comments

This paper describes an interesting randomized controlled clinical trial that demonstrated the higher efficacy of Kampo treatment than fenoprofen (an antipyretic used for fever associated with common cold). In this trial, 246 patients with common cold were allocated to two groups using sealed envelopes. Of these, 80 patients with fever were selected as subjects in the trial. Allocation using sealed envelopes is often associated with poor maintenance of randomization, and, furthermore, a two-step selection process was used in this trial. Future studies are expected to improve randomization and include a placebo group.

12. Abstractor and date

参照

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